Two-Hour Session Will Feature Two Live Cases; Pooled Analysis of Bifurcation Stent System Will Examine Evidence from Eight Clinical Studies
DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
      definitively treat bifurcation lesions, today announced activities
      highlighting the latest experience with the TRYTON Side Branch Stent at
      EuroPCR, the official congress of the European Association of
      Percutaneous Cardiovascular Interventions, taking place at the Palais
      des Congrès May 15-18, 2012 in Paris.
    
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        On Wednesday, May 16 from 2:00 p.m. to 4:00 p.m. in the Theatre
Bordeaux, William Wijns, M.D., and Martin B. Leon, M.D., will chair a
“Tools and Techniques” session featuring two live transmissions of
patients treated using the Tryton stent by Eulogio Garcia, M.D., of
the Hospital Clinico San Carlos in Madrid, Spain. - 
        On Thursday, May 17, at 11:22 a.m. in Room 341, Maik Grundeken, M.D.,
of the Department of Cardiology at the University of Amsterdam in the
Netherlands, will present a patient-level pooled analysis of six-month
clinical outcomes from more than 900 patients treated with the Tryton
stent in eight post-marketing registries. - 
        In addition, the conference will feature more than 10 Tryton case
reports and three abstracts presenting data related to the Tryton
stent system. 
      The Tryton stent has now been used to treat approximately 5,000 patients
      and is commercially available throughout Europe, Russia and the Middle
      East. The company recently began enrollment in the first and only
      randomized controlled U.S. IDE pivotal clinical trial evaluating a
      dedicated bifurcation stent. The 704-patient study compares a Tryton
      stent in the side branch vs. the use of balloon angioplasty in the side
      branch, with both arms of the trial utilizing a standard drug eluting
      stent in the main vessel. The trial has completed its IVUS angiographic
      sub study cohorts and enrollment remains on schedule to complete
      enrolllment later this year. The results of the trial will be submitted
      to the U.S. Food and Drug Administration (FDA) for approval to market
      the device in the United States.
    
      Clinical data presented on more than 1,000 patients treated with the
      Tryton stent has demonstrated consistent target lesion revascularization
      rates of less than four percent and low thrombosis rates at six-month
      follow up and beyond.
    
About Coronary Bifurcation Disease
      Coronary artery disease often results in the buildup of plaque at the
      site of a bifurcation, where one artery branches from another. Current
      approaches to treating these lesions are time consuming and technically
      difficult. As a result, the side branch is often left unstented, leaving
      it vulnerable to higher rates of restenosis, the re-narrowing of the
      stented vessel following implantation.1 In patients
      undergoing PCI-stenting, approximately one-third have a bifurcation
      lesion. Left main disease, an accumulation of plaque that narrows the
      base of the coronary tree, is a persistent challenge in interventional
      cardiology, as more than 75 percent of left main lesions are bifurcation
      lesions.
    
About the Tryton Side Branch Stent
      The Tryton Side Branch Stent System is built for bifurcation using
      proprietary Tri-zone™ technology to offer a dedicated strategy for
      treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed
      in the side branch artery using a standard single-wire
      balloon-expandable stent delivery system. A conventional drug-eluting
      stent is then placed in the main vessel. The stent system has received
      CE Mark and is commercially available throughout Europe, Russia and the
      Middle East. It is approved in the United States for investigational use
      only.
    
About the Randomized Tryton IDE Pivotal Study
      The landmark Tryton pivotal study is a multi-national randomized trial
      that compares a Tryton stent in the side branch vs. the use of balloon
      angioplasty in the side branch, with both arms of the trial utilizing a
      standard drug eluting stent in the main vessel. The study, which is the
      first and only randomized IDE pivotal clinical trial evaluating a
      dedicated bifurcation stent, will enroll 704 patients at up to 75
      centers in North America, Europe and Israel. Martin Leon, M.D. (Columbia
      University, New York) serves as principal investigator for the study and
      Patrick Serruys (Thoraxcenter, Rotterdam) is leading IVUS and
      three-dimensional angiographic analysis.
    
About Tryton Medical, Inc.
      Tryton Medical, Inc., located in Durham, N.C., is a leading developer of
      novel stent systems for the treatment of bifurcation lesions. The
      company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of
      medicine at Dartmouth Medical School/Dartmouth- Hitchcock Medical
      Center) and Dan Cole to develop stents for the definitive treatment of
      bifurcation lesions. Privately held, Tryton is backed by Arnerich
      Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest
      Ventures. For more information please visit trytonmedical.com.
    
       Tryton Medical, Inc.
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com     
